Read our latest updates & insights

On 2 October 2024, South Korea-headquartered ABL Bio announced it has entered a clinical collaboration and supply agreement with MSD to evaluate the bispecific antibody ABL 103 in combination with MSD’s Keytruda® (pembrolizumab) in patients with advanced or metastatic solid...

On 1 October 2024, AstraZeneca and Daiichi Sankyo’s supplemental Biologics Licence Application for Enhertu® (fam-trastuzumab deruxtecan-nxki) was granted priority review by the US FDA.  The treatment is proposed to be used in HER2-low or HER2 ultra-low unresectable or metas...

On 1 October 2024, Johnson & Johnson (J&J) announced a $2b investment in a new, advanced technology biologics manufacturing facility in North Carolina.  J&J states that the new facility will expand production of the company’s biologics portfolio and pipeline as ...

On 1 October 2024, the prestigious journal Nature published an article describing a retrospective cohort study comparing the efficacy of Evenity® (romosozumab) and Prolia® (denosumab) in treating male osteoporosis over 12 months, focusing on bone mineral density (BMD) chang...

On 30 September 2024, the Australian Therapeutic Goods Administration (TGA), in collaboration with the Australian Border Force (ABF), issued a notice advising of the detection of counterfeit Ozempic®-labelled pens being imported into Australia.

The TGA warns that the...

On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.  On the same dat...

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, p...

On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA.  The European approval is for moderately to severely active Crohn’s disea...

On 27 September, AbbVie announced that it submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR...